What is Biological Evaluation Report?
We prepare Biological Evaluation Reports (BERs) in accordance with ISO 10993-1, providing a clear, structured, and scientifically justified assessment of the biological safety of medical devices.
Our BERs consolidate all relevant information generated during the biological evaluation process, including materials and device configuration, manufacturing and sterilisation processes, chemical characterisation, biocompatibility testing, toxicological assessments, and available clinical or post‑market data.
Each BER is developed using a risk‑based, life‑cycle approach, ensuring that biological risks are assessed in the context of how the device is manufactured, stored, used clinically, and, where applicable, reprocessed or used long‑term.
We critically review all available data, integrate results from any required testing identified in the Biological Evaluation Plan (BEP), and provide clear conclusions supported by robust scientific rationale on whether biological risks are acceptable for the device’s intended use.
As a result, our BERs provide:
Clear and defensible biological safety conclusions. A consolidated assessment showing how identified biological risks have been evaluated and addressed for the device’s intended use.
Strong scientific rationale. Integrated justification based on biological testing, chemical characterisation, toxicological evaluation, and existing data, presented in a clear and traceable manner.
Well-structured documentation. A coherent, standard-aligned report that supports technical documentation and ongoing compliance activities.
What is a BER gap analysis?
We also offer Biological Evaluation Report (BER) review and gap analysis services to assess alignment with the latest ISO 10993‑1:2025 requirements.
This service involves a structured review of your existing BER to identify gaps, inconsistencies, or areas requiring update in relation to current expectations, including risk‑based decision‑making, life‑cycle considerations, use of chemical characterisation data, and integration with ISO 14971 risk management.
The outcome is a clear, actionable gap analysis that defines whether the existing BER remains acceptable, requires targeted updates, or needs more substantial revision, helping you maintain compliance and confidence as standards and regulatory expectations evolve.
Our BER services are delivered in close alignment with your risk management documentation and ISO 14971 processes.
Biological hazards, risk evaluations, and risk control measures identified within the BER are clearly linked to the risk management file, ensuring consistency between biological safety conclusions and the overall risk management strategy.
Where relevant, we support the justification of residual biological risks and demonstrate how these risks have been reduced to an acceptable level.
This integrated approach helps ensure that biological safety is fully embedded within your technical documentation, supporting a clear, traceable, and regulator‑ready risk management framework.
Frequently Asked Questions
How do I bring an existing BER in line with ISO 10993‑1:2025?
To align an existing BER with ISO 10993‑1:2025, a structured BER review and gap analysis should be performed. This involves assessing the report against updated requirements, including enhanced life‑cycle considerations, use of chemical characterisation data, alignment with risk management documentation, and justification of biological endpoints. The outcome defines whether the BER remains acceptable, requires targeted updates, or needs more extensive revision.
How long does it take to prepare a Biological Evaluation Report (BER)?
The timeline for preparing a BER depends on the complexity of the device, the availability and quality of existing data, and whether additional biological testing or chemical characterisation is required.
Where data are already available and complete, a BER can often be prepared within 2–3 weeks.
Devices requiring data gap resolution, new testing, or updates to align with ISO 10993‑1:2025 may require additional time.
To avoid delays, it is recommended that BER preparation is planned early and aligned with the Biological Evaluation Plan (BEP) and overall development and regulatory timelines.
Is biological evaluation a one‑time activity?
No. Biological evaluation is a living process that should be maintained throughout the device life cycle. As devices evolve, new data become available, or standards are updated, the biological evaluation and supporting documentation may need to be reviewed and revised to remain current.
Who is responsible for ensuring ISO 10993‑1 compliance?
The manufacturer is ultimately responsible for ensuring compliance with ISO 10993‑1. However, the standard requires that biological evaluations are planned, conducted, and documented by knowledgeable and experienced professionals, which is why many manufacturers engage specialist support.
Is biocompatibility testing alone is enough to demonstrate compliance?
Testing is only one part of the biological evaluation. ISO 10993‑1 requires a documented evaluation, typically in the form of a Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER), which assess all available data and provide scientific justification for conclusions.